The Role of Tiotropium+Olodaterol Dual Bronchodilator Therapy in the Management of Chronic Obstructive Pulmonary Disease

다국어 초록 (Multilingual Abstract)

Bronchodilator therapy is central to the management of chronic obstructive pulmonary disease and are recommended as the preferred treatment by the Global Obstructive Lung Disease Initiative (GOLD). Long acting anti-muscarinics (LAMA) and long acting ${\beta}_2$ agonists (LABA) are both more effective than regular short-acting drugs but many patients remain symptomatic despite monotherapy with these drugs. Combination therapy with LAMA and LABA increases the therapeutic benefit while minimizing dose-dependent side effects of long-acting bronchodilator therapy. The TOviTO programme has investigated the benefits of treatment with a combination of tiotropium and olodaterol administered via a single inhaler. Tiotropium+olodaterol $5/5{\mu}g$ significantly improved forced expiratory volume in 1 second ($FEV_1$) area under the curve from 0 to 3 hours, trough $FEV_1$ health status and breathlessness versus the mono-components and placebo. Tiotropium+olodaterol $5/5{\mu}g$ also increased endurance time and reduced dynamic hyperinflation during constant work rate cycle ergometry. On the basis of these and other studies the 2017 GOLD report recommends escalating to dual bronchodilator therapy in patients in groups B and C if they remain symptomatic or continue to have exacerbations and as initial therapy for patients in group D.

참고문헌 (Reference)

1 Thomas M, "When is dual bronchodilation indicated in COPD?" 12 : 2291-2305, 2017

2 Toy EL, "Treatment of COPD: relationships between daily dosing frequency, adherence, resource use, and costs" 105 : 435-441, 2011

3 Keating GM, "Tiotropium bromide inhalation powder: a review of its use in the management of chronic obstructive pulmonary disease" 72 : 273-300, 2012

4 Buhl R, "Tiotropium and olodaterol fixed-dose combination versus mono-components in COPD (GOLD 2-4)" 45 : 969-979, 2015

5 Keating GM, "Tiotropium Respimat((R)) Soft Mist inhaler: a review of its use in chronic obstructive pulmonary disease" 74 : 1801-1816, 2014

6 Singh D, "Tiotropium + olodaterol shows clinically meaningful improvements in quality of life" 109 : 1312-1319, 2015

7 Walker PP, "The volumetric response to bronchodilators in stable chronic obstructive pulmonary disease" 5 : 147-152, 2008

8 Wedzicha JA, "The prevention of chronic obstructive pulmonary disease exacerbations by salmeterol/fluticasone propionate or tiotropium bromide" 177 : 19-26, 2008

9 "Spiolto Respimat in COPD [Internet]" Boehringer Ingelheim

10 Pisi R, "Small airway dysfunction and flow and volume bronchodilator responsiveness in patients with chronic obstructive pulmonary disease" 10 : 1191-1197, 2015

11 Calverley PM, "Salmeterol and fluticasone propionate and survival in chronic obstructive pulmonary disease" 356 : 775-789, 2007

12 Punekar YS, "Rescue medication use as a patient-reported outcome in COPD: a systematic review and regression analysis" 18 : 86-, 2017

13 Donohue JF, "Relationship between change in trough FEV1 and COPD patient outcomes: pooled analysis of 23 clinical trials in patients with COPD" 46 (46): PA1013-, 2015

14 Ram FS, "Regular inhaled short acting ${\beta}_{2}$ agonists for the management of stable chronic obstructive pulmonary disease: Cochrane systematic review and meta-analysis" 58 : 580-584, 2003

15 Aalbers R, "Randomized, double-blind, dosefinding study for tiotropium when added to olodaterol, administered via the Respimat(R) inhaler in patients with chronic obstructive pulmonary disease" 32 : 809-822, 2015

16 Bouyssou T, "Pharmacological characterization of olodaterol, a novel inhaled ${\beta}_{2}$-adrenoceptor agonist exerting a 24-hourlong duration of action in preclinical models" 334 : 53-62, 2010

17 Beeh KM, "Once-daily NVA237 improves exercise tolerance from the first dose in patients with COPD: the GLOW3 trial" 7 : 503-513, 2012

18 Singh D, "New combination bronchodilators for chronic obstructive pulmonary disease: current evidence and future perspectives" 79 : 695-708, 2015

19 Donohue JF, "Magnitude of umeclidinium/vilanterol lung function effect depends on monotherapy responses: results from two randomised controlled trials" 112 : 65-74, 2016

20 Koch A, "Lung function efficacy and symptomatic benefit of olodaterol once daily delivered via Respimat(R) versus placebo and formoterol twice daily in patients with GOLD 2-4 COPD: results from two replicate 48-week studies" 9 : 697-714, 2014

21 Chapman KR, "Long-term safety and efficacy of indacaterol, a long-acting ${\beta}_{2}$-agonist, in subjects with COPD: a randomized, placebo-controlled study" 140 : 68-75, 2011

22 Busch-Petersen J, "Inhaled long-acting muscarinic antagonists in chronic obstructive pulmonary disease" 3 : 1623-1634, 2011

23 Gross N, "Inhalation by nebulization of albuterol-ipratropium combination (Dey combination) is superior to either agent alone in the treatment of chronic obstructive pulmonary disease. Dey Combination Solution Study Group" 65 : 354-362, 1998

24 Wedzicha JA, "Indacaterol-glycopyrronium versus salmeterol-fluticasone for COPD" 374 : 2222-2234, 2016

25 COMBIVENT Inhalation Aerosol Study Group, "In chronic obstructive pulmonary disease, a combination of ipratropium and albuterol is more effective than either agent alone: an 85-day multicenter trial" 105 : 1411-1419, 1994

26 Brand P, "Higher lung deposition with Respimat Soft Mist inhaler than HFAMDI in COPD patients with poor technique" 3 : 763-770, 2008

27 Vogelmeier CF, "Global strategy for the diagnosis, management, and prevention of chronic obstructive lung disease 2017 report. GOLD Executive Summary" 195 : 557-582, 2017

28 Ferguson GT, "Efficacy of tiotropium + olodaterol in patients with chronic obstructive pulmonary disease by initial disease severity and treatment intensity: a post hoc analysis" 32 : 523-536, 2015

29 Ferguson GT, "Efficacy and safety of tiotropium + olodaterol maintenance treatment in patients with COPD in the TONADO(R) and OTEMTO(R) studies: a subgroup analysis by age" 11 : 2701-2710, 2016

30 D'Urzo A, "Efficacy and safety of once-daily NVA237 in patients with moderate-to-severe COPD: the GLOW1 trial" 12 : 156-, 2011

31 Ferguson GT, "Efficacy and safety of olodaterol once daily delivered via Respimat(R) in patients with GOLD 2-4 COPD: results from two replicate 48-week studies" 9 : 629-645, 2014

32 Vogelmeier CF, "Efficacy and safety of direct switch to indacaterol/glycopyrronium in patients with moderate COPD: the CRYSTAL open-label randomised trial" 18 : 140-, 2017

33 ZuWallack R, "Efficacy and safety of combining olodaterol Respimat((R)) and tiotropium HandiHaler((R)) in patients with COPD: results of two randomized, double-blind, active-controlled studies" 9 : 1133-1144, 2014

34 Kerwin EM, "Efficacy and safety of a 12-week treatment with twice-daily aclidinium bromide in COPD patients (ACCORD COPD I)" 9 : 90-101, 2012

35 O'Donnell DE, "Effects of tiotropium on lung hyperinflation, dyspnoea and exercise tolerance in COPD" 23 : 832-840, 2004

36 Singh D, "Effects of tiotropium + olodaterol versus tiotropium or placebo by COPD disease severity and previous treatment history in the OTEMTO(R) studies" 17 : 73-, 2016

37 Martinez FJ, "Effects of symptom severity at baseline on lungfunction and SGRQ responses in the OTEMTO studies" 193 : A6787-, 2016

38 Maltais F, "Effects of 12 weeks of once-daily tiotropium and olodaterol fixed-dose combination on exercise endurance in patients with COPD" 69 (69): A186-A187, 2014

39 Halpin DM, "Effect of tiotropium on COPD exacerbations: a systematic review" 114 : 1-8, 2016

40 Ferguson GT, "Effect of tiotropium and olodaterol on symptoms and patient-reported outcomes in patients with COPD: results from four randomised, double-blind studies" 27 : 7-, 2017

41 O'Donnell DE, "Effect of indacaterol on exercise endurance and lung hyperinflation in COPD" 105 : 1030-1036, 2011

42 O'Donnell DE, "Dynamic hyperinflation and exercise intolerance in chronic obstructive pulmonary disease" 164 : 770-777, 2001

43 Cohen JS, "Dual therapy strategies for COPD: the scientific rationale for LAMA + LABA" 11 : 785-797, 2016

44 Dransfield MT, "Disease severity and symptoms among patients receiving monotherapy for COPD" 20 : 46-53, 2011

45 Jones PW, "Correlating changes in lung function with patient outcomes in chronic obstructive pulmonary disease: a pooled analysis" 12 : 161-, 2011

46 Rossi A, "Comparison of the efficacy, tolerability, and safety of formoterol dry powder and oral, slow-release theophylline in the treatment of COPD" 121 : 1058-1069, 2002

47 Tashkin DP, "Combination bronchodilator therapy in the management of chronic obstructive pulmonary disease" 14 : 49-, 2013

48 Calverley PM, "Bronchodilator reversibility testing in chronic obstructive pulmonary disease" 58 : 659-664, 2003

49 Maltais F, "Aclidinium bromide improves exercise endurance and lung hyperinflation in patients with moderate to severe COPD" 105 : 580-587, 2011

50 Calverley PM, "AJRCCM: 100-year anniversary. Physiology and chronic obstructive pulmonary disease in the blue journals" 195 : 1088-1090, 2017

51 Donohue JF, "A 6-month, placebo-controlled study comparing lung function and health status changes in COPD patients treated with tiotropium or salmeterol" 122 : 47-55, 2002

52 Tashkin DP, "A 4-year trial of tiotropium in chronic obstructive pulmonary disease" 359 : 1543-1554, 2008